Trial Outcomes & Findings for A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC) (NCT NCT04556383)
NCT ID: NCT04556383
Last Updated: 2023-08-01
Results Overview
Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
236 participants
Primary outcome timeframe
At PCP Week 12
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
Placebo-Controlled Period (PCP) Placebo
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
PCP GB004 480 mg BID for oral administration for 36 weeks
|
Open-Label Extension (OLE) GB004 480 mg BID
OLE GB004 480 mg BID for oral administration for 24 weeks
|
|---|---|---|---|---|
|
PCP
STARTED
|
78
|
78
|
80
|
0
|
|
PCP
COMPLETED
|
23
|
25
|
26
|
0
|
|
PCP
NOT COMPLETED
|
55
|
53
|
54
|
0
|
|
OLE
STARTED
|
0
|
0
|
0
|
130
|
|
OLE
COMPLETED
|
0
|
0
|
0
|
39
|
|
OLE
NOT COMPLETED
|
0
|
0
|
0
|
91
|
Reasons for withdrawal
| Measure |
Placebo-Controlled Period (PCP) Placebo
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
PCP GB004 480 mg BID for oral administration for 36 weeks
|
Open-Label Extension (OLE) GB004 480 mg BID
OLE GB004 480 mg BID for oral administration for 24 weeks
|
|---|---|---|---|---|
|
PCP
Lack of Efficacy
|
28
|
23
|
23
|
0
|
|
PCP
Study terminated by sponsor
|
15
|
13
|
16
|
0
|
|
PCP
Withdrawal by Subject
|
8
|
6
|
6
|
0
|
|
PCP
Adverse Event
|
1
|
7
|
7
|
0
|
|
PCP
Other, Not Specified
|
1
|
2
|
1
|
0
|
|
PCP
Protocol Violation
|
1
|
0
|
1
|
0
|
|
PCP
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
PCP
Physician Decision
|
0
|
1
|
0
|
0
|
|
PCP
Site terminated by sponsor
|
0
|
1
|
0
|
0
|
|
OLE
Study terminated by sponsor
|
0
|
0
|
0
|
68
|
|
OLE
Withdrawal by Subject
|
0
|
0
|
0
|
10
|
|
OLE
Lack of Efficacy
|
0
|
0
|
0
|
7
|
|
OLE
Adverse Event
|
0
|
0
|
0
|
2
|
|
OLE
Other, Not Specified
|
0
|
0
|
0
|
2
|
|
OLE
Death
|
0
|
0
|
0
|
1
|
|
OLE
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
Baseline characteristics by cohort
| Measure |
PCP Placebo
n=78 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=78 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=80 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.1 Years
STANDARD_DEVIATION 14.86 • n=5 Participants
|
44.3 Years
STANDARD_DEVIATION 13.79 • n=7 Participants
|
45.1 Years
STANDARD_DEVIATION 16.76 • n=5 Participants
|
44.8 Years
STANDARD_DEVIATION 15.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
77 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At PCP Week 12Population: PCP Intent to Treat (ITT) Population: all participants who were randomized and received at least 1 dose of PCP study treatment
Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Outcome measures
| Measure |
PCP Placebo
n=78 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=78 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=80 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Clinical Remission at PCP Week 12
|
17.9 percentage of participants
Interval 11.0 to 27.9
|
15.4 percentage of participants
Interval 9.0 to 25.0
|
22.5 percentage of participants
Interval 14.7 to 32.8
|
PRIMARY outcome
Timeframe: From first dose of OLE study treatment through OLE Week 28Population: OLE Safety Population: all participants who received at least 1 dose of OLE study treatment
An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study treatment. Abnormal laboratory test results or other safety assessments, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator were to be reported as AEs. An AE was considered treatment-emergent to the OLE if it started on or after the first dose of OLE study treatment.
Outcome measures
| Measure |
PCP Placebo
n=130 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With a Treatment Emergent Adverse Event
|
32.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At PCP Week 12Population: PCP ITT Population: all participants who were randomized and received at least 1 dose of PCP study treatment
Clinical response is defined as a reduction in Modified Mayo score of ≥ 2 points and ≥ 35% from baseline, including a decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Outcome measures
| Measure |
PCP Placebo
n=78 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=78 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=80 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Clinical Response at PCP Week 12
|
42.3 percentage of participants
Interval 32.0 to 53.4
|
34.6 percentage of participants
Interval 25.0 to 45.7
|
52.5 percentage of participants
Interval 41.7 to 63.1
|
SECONDARY outcome
Timeframe: At PCP Week 12Population: Participants in the PCP ITT Population (all participants who were randomized and received at least 1 dose of PCP study treatment) with baseline lamina propria neutrophils and neutrophils in the epithelium RHI subscores \> 0.
Histologic remission is defined as Robarts Histopathology Index (RHI) ≤ 3 with lamina propria neutrophils RHI subscore = 0 and neutrophils in epithelium RHI subscore = 0. Histologic remission is evaluated among subjects with both baseline lamina propria neutrophils and neutrophils in epithelium RHI subscores \> 0. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.
Outcome measures
| Measure |
PCP Placebo
n=69 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=68 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=70 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Histologic Remission at PCP Week 12
|
26.1 percentage of participants
Interval 17.2 to 37.5
|
26.5 percentage of participants
Interval 17.4 to 38.0
|
32.9 percentage of participants
Interval 23.0 to 44.5
|
SECONDARY outcome
Timeframe: At PCP Week 12Population: PCP Intent to Treat (ITT) Population: all participants who were randomized and received at least 1 dose of PCP study treatment
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. The endoscopic subscore is a component of the Modified Mayo score and is assessed on a 0-3 scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate greater endoscopic disease severity. An endoscopic subscore of 1 does not include friability; an endoscopy with friability is assessed an endoscopic subscore of at least 2.
Outcome measures
| Measure |
PCP Placebo
n=78 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=78 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=80 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Endoscopic Improvement at PCP Week 12
|
21.8 percentage of participants
Interval 14.1 to 32.2
|
23.1 percentage of participants
Interval 15.1 to 33.6
|
30.0 percentage of participants
Interval 21.1 to 40.8
|
SECONDARY outcome
Timeframe: At PCP Week 12Population: Participants in the PCP ITT Population (all participants who were randomized and received at least 1 dose of PCP study treatment) with baseline lamina propria neutrophils and neutrophils in the epithelium RHI subscores \> 0.
Mucosal healing is defined as endoscopic improvement and histologic remission. Please see Secondary Outcome Measure Descriptions above for Percentage of Participants With Endoscopic Improvement at PCP Week 12 and for Percentage of Participants With Histologic Remission at PCP Week 12 for information on the measures of endoscopic improvement and histologic remission, respectively.
Outcome measures
| Measure |
PCP Placebo
n=69 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=68 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=70 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Mucosal Healing at PCP Week 12
|
17.4 percentage of participants
Interval 10.2 to 28.0
|
16.2 percentage of participants
Interval 9.3 to 26.7
|
20.0 percentage of participants
Interval 12.3 to 30.8
|
SECONDARY outcome
Timeframe: At PCP Week 36Population: PCP ITT Population: all participants who were randomized and received at least 1 dose of PCP study treatment. Participants who did not consent to protocol version 2.0 and participants who withdrew from PCP due to study termination by Sponsor are excluded from the analysis.
Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Outcome measures
| Measure |
PCP Placebo
n=63 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=64 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=62 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Clinical Remission at PCP Week 36
|
14.3 percentage of participants
Interval 7.7 to 25.0
|
7.8 percentage of participants
Interval 3.4 to 17.0
|
12.9 percentage of participants
Interval 6.7 to 23.4
|
SECONDARY outcome
Timeframe: At PCP Week 36Population: PCP ITT Population: all participants who were randomized and received at least 1 dose of PCP study treatment. Participants who did not consent to protocol version 2.0 and participants who withdrew from PCP due to study termination by Sponsor are excluded from the analysis.
Clinical response is defined as a reduction in Modified Mayo score of ≥ 2 points and ≥ 35% from baseline, including a decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Outcome measures
| Measure |
PCP Placebo
n=63 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=64 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=62 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Clinical Response at PCP Week 36
|
20.6 percentage of participants
Interval 12.5 to 32.2
|
23.4 percentage of participants
Interval 14.7 to 35.1
|
29.0 percentage of participants
Interval 19.2 to 41.3
|
SECONDARY outcome
Timeframe: At PCP Week 36Population: Participants in the PCP ITT Population (all participants who were randomized and received at least 1 dose of PCP study treatment) with baseline lamina propria neutrophils and neutrophils in the epithelium RHI subscores \> 0. Participants who did not consent to protocol version 2.0, participants who withdrew from PCP due to study termination by Sponsor, and participants for whom biopsies were collected and not centrally read due to study termination by Sponsor are excluded from the analysis.
Histologic remission is defined as Robarts Histopathology Index (RHI) ≤ 3 with lamina propria neutrophils RHI subscore = 0 and neutrophils in epithelium RHI subscore = 0. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.
Outcome measures
| Measure |
PCP Placebo
n=49 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=48 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=50 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Histologic Remission at PCP Week 36
|
14.3 percentage of participants
Interval 7.1 to 26.7
|
8.3 percentage of participants
Interval 3.3 to 19.6
|
16.0 percentage of participants
Interval 8.3 to 28.5
|
SECONDARY outcome
Timeframe: At PCP Week 36Population: PCP ITT Population: all participants who were randomized and received at least 1 dose of PCP study treatment. Subjects who did not consent to protocol version 2.0 and subjects who withdrew from PCP due to study termination by Sponsor are excluded from the analysis.
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. The endoscopic subscore is a component of the Modified Mayo score and is assessed on a 0-3 scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate greater endoscopic disease severity. An endoscopic subscore of 1 does not include friability; an endoscopy with friability is assessed an endoscopic subscore of at least 2.
Outcome measures
| Measure |
PCP Placebo
n=63 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=64 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=62 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Endoscopic Improvement at PCP Week 36
|
15.9 percentage of participants
Interval 8.9 to 26.8
|
15.6 percentage of participants
Interval 8.7 to 26.4
|
12.9 percentage of participants
Interval 6.7 to 23.4
|
SECONDARY outcome
Timeframe: At PCP Week 36Population: Participants in the PCP ITT Population (all participants who were randomized and received at least 1 dose of PCP study treatment) with baseline lamina propria neutrophils and neutrophils in the epithelium RHI subscores \> 0. Participants who did not consent to protocol version 2.0, participants who withdrew from PCP due to study termination by Sponsor, and participants for whom biopsies were collected and not centrally read due to study termination by Sponsor are excluded from the analysis.
Mucosal healing is defined as endoscopic improvement and histologic remission. Please see Secondary Outcome Measure Descriptions above for Percentage of Participants With Endoscopic Improvement at PCP Week 36 and for Percentage of Participants With Histologic Remission at PCP Week 36 for information on the measures of endoscopic improvement and histologic remission, respectively.
Outcome measures
| Measure |
PCP Placebo
n=49 Participants
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=48 Participants
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=50 Participants
PCP GB004 480 mg BID for oral administration for 36 weeks
|
|---|---|---|---|
|
Percentage of Participants With Mucosal Healing at PCP Week 36
|
14.3 percentage of participants
Interval 7.1 to 26.7
|
6.3 percentage of participants
Interval 2.1 to 16.8
|
12.0 percentage of participants
Interval 5.6 to 23.8
|
Adverse Events
PCP Placebo
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
PCP GB004 480 mg QD
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
PCP GB004 480 mg BID
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
OLE GB004 480 mg BID
Serious events: 9 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PCP Placebo
n=78 participants at risk
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=76 participants at risk
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=82 participants at risk
PCP GB004 480 mg BID for oral administration for 36 weeks
|
OLE GB004 480 mg BID
n=130 participants at risk
OLE GB004 480 mg BID for oral administration for 24 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.77%
1/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.3%
1/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
2.6%
2/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
3.1%
4/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
1.2%
1/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
1.2%
1/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.77%
1/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Infections and infestations
COVID-19
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.77%
1/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.77%
1/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
1.2%
1/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Nervous system disorders
Syncope
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.77%
1/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
1.2%
1/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
Other adverse events
| Measure |
PCP Placebo
n=78 participants at risk
PCP Placebo for oral administration for 36 weeks
|
PCP GB004 480 mg QD
n=76 participants at risk
PCP GB004 480 mg QD for oral administration for 36 weeks
|
PCP GB004 480 mg BID
n=82 participants at risk
PCP GB004 480 mg BID for oral administration for 36 weeks
|
OLE GB004 480 mg BID
n=130 participants at risk
OLE GB004 480 mg BID for oral administration for 24 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
18.4%
14/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
9.8%
8/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
2/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
14.5%
11/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
4.9%
4/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Nervous system disorders
Somnolence
|
1.3%
1/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
6.6%
5/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
8.5%
7/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
General disorders
Fatigue
|
1.3%
1/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
1.3%
1/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
6.1%
5/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Nervous system disorders
Headache
|
0.00%
0/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
5.3%
4/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
2.4%
2/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
6.6%
5/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Infections and infestations
COVID-19
|
6.4%
5/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
5.3%
4/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
4.9%
4/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
6.2%
8/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
4/78 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
2.6%
2/76 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
2.4%
2/82 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
0.00%
0/130 • PCP: From first dose in PCP through first dose in OLE (if participant was dosed in OLE) or through PCP Week 40 (if participant was not dosed in OLE) OLE: From first dose in OLE through OLE Week 28
Number of participants at risk based on PCP safety population (all participants who received at least 1 dose of PCP study treatment, grouped according to highest dose of GB004 received) for PCP Reporting Groups and OLE safety population (all participants who received at least 1 dose of OLE study treatment) for OLE Reporting Group. Differences between PCP ITT and safety populations due to 2 participants randomized to GB004 480 mg QD but erroneously received and dosed GB004 480 mg BID.
|
Additional Information
GB004, Inc. Study Director
GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Phone: 1-866-668-4083
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place